Man has created his own world by application of his brain or mind and by utilization of natural resources. Man has also been bestowed with imagination and creativity. With his imagination and creativity, he has been producing various articles or products for his needs, comfort and convenience. In the earlier era, the creations and inventions by him fell in a public domain. These were the common properties. Anybody could use and copy these creations and inventions without any restriction, reservation or payment. However, with the passage of time, the importance and value of these creations was realized. The commercial aspect started playing a significant role in these creations. By end of Twentieth Century, the things created and invented by the human mind were recognized as an intellectual property of the owner. The owner’s right over these properties was accepted and is known as an Intellectual Property Right (commonly called I.P.R.). A new set of laws called Intellectual Property Right Laws, were enacted to protect these property rights. These I.P.R. laws provided a protection to the owners under different categories and names like Patents, Industrial designs, Copyrights, Trade- Marks etc.   Intellectual Property (IP) The capability of the brain to think and imagine something innovative or novel is known as ‘intellect’. When someone possesses such an intellect, which can be used to invent something for the benefit of the society/masses, then the invention becomes his property, for which he can possess all the rights to use it the way he likes. Eg: idea, business method, invention etc.   Intellectual Property Rights (IPR) As the name indicates Intellectual Property Rights are exclusive rights over the creations of the mind. A creator can have exclusive rights over his creation for a certain period of time depending upon the type of Intellectual Property.   Significance of Intellectual Property Rights The intellectual property rights were essentially recognized and accepted all over the world due to some very important reasons. Some of the reasons for accepting these rights are:- a). To provide incentive to the individual for new creations. b). providing due recognition to the creators and inventors. c). Ensuring material reward for intellectual property. d). Ensuring the availability of the genuine and original products   International organization for IP control

1. World Intellectual Property Organization (WIPO)

India is a member of World Intellectual Property Organization (WIPO), an international organization responsible for the promotion and protection of intellectual property throughout the world. The World Intellectual Property Organization (WIPO) is a specialized agency of the United Nations which is dedicated to ensuring that the rights of creators and owners of intellectual property are protected worldwide. It is of the view that the inventors and authors should be rewarded for their ingenuity. WIPO’s main objective is ‘to promote the protection of intellectual property throughout the world through cooperation among States and, where appropriate, in collaboration with any other international organization’. The important features of the convention are as follows:

• National treatment
• Parallel importation
• Right of priority
• Independence of patents
• Protection against false indication and unfair competition.

However, the main objective of the convention is to give protection for obtaining, maintaining and enforcing the industrial property of the member nations. The member nations of the Paris Convention have the advantages that they alone can be the members of various international conventions and treaties. Through its member state and secretariat, WIPO seeks to Provide services for international application for industrial property rights,

• Exchange intellectual property information among member countries,
• Provide legal and technical assistance to developing and other countries and
• Resolve the private disputes on intellectual property and harmonizes the intellectual property (IP) laws and procedures.

WIPO was established by the convention of 14 July 1967, which entered into force in 1970. Since 1974, it has been a specialized agency administering a number of international unions or treaties in the area of intellectual property like Paris and Berne Conventions.  

2. General Agreement on Tariffs and Trade (GATT)

GATT was signed in 1947, and came into force on 1 January 1948 signed by 23 states. It was amended in 1966 and lasted until 1993, when it was replaced by the WTO in 1995. It was required after the World War II to revitalize the world trade and encourage the countries to participate freely. It is one of the important agencies of the United Nations, which provides better and wider protection for the private patent holders of the developed nations than the Paris Convention. The purpose of the GATT was the ‘substantial reduction of tariffs and other trade barriers and the elimination of preferences, on a reciprocal and mutually advantageous basis’. Under the GATT, eight rounds of negotiations took place to liberalize world trade. The last round was the Uruguay Round, which was completed on 15 December 1993.  

3. World Trade Organization (WTO)

World Trade Organization (WTO) is the successor organization to the General Agreement on Tariffs and Trade (GATT). In 1995, WTO was established, which replaced the GATT. WTO intends to supervise and liberalize international trade, and officially commenced on       1 January 1995. The organization dealt with trade regulation among the member countries. It had 157 members (till 2012) of which 117 are developing countries. The headquarters of WTO is at Geneva, Switzerland. Its activities are supported by a secretariat of some 700 staff, led by the WTO Director General. There are three official languages of WTO: English, French and Spanish. Decisions are generally taken by consensus of the entire membership representing more than 97% of the world’s population. The highest institutional body is the Ministerial Conference, which meets roughly once in every two years. Below this is the General Council, which normally consists of ambassadors and heads of delegation in Geneva, but sometimes officials sent from members’ capitals are also included, which meets several times a year in the Geneva headquarters. The General Council acts as Trade Policy Review Body and the Dispute Settlement Body. The Goods Council, Services Council and Intellectual Property (TRIPs) Council report to the General Council. There are other specialized committees, working groups and working parties which deal with the individual agreements and other areas such as the environment, development, membership applications and regional trade agreements. WTO has several benefits like the system helps in promoting peace, helps in dispute settlement, makes rules that make life easier for all, conducts freer trade that cuts the costs of living, provides more choice of products and qualities, income that is due is raised and governments are shielded from lobbying. Moreover, the system encourages good government. More specifically, its main objective is to help trade flow smoothly, freely, fairly and predictably at the international level. International trade is beneficial to all the countries and their citizens. It is a fact that trade leads to growth, which in turn promotes national development and reduces poverty. The following are its activities:

• Negotiation to reduce or eradicate hindrances in trade (e.g. import tariffs and other barriers to trade) and agreeing on rules that govern the conduct of internal trade (anti-dumping, subsidies, product standards etc.)
• Administrating and monitoring the application of WTO trade agreement rules in goods, trade in services, IPR
• Reviewing the trade-related policies of WTO members as well as ensuring transparency in regional and bilateral trade agreement
• Settling disputes among its members regarding interpretation and application of the trade agreement
• Educating public about WTO, its mission and its activities
• Conducting economic research
• Assisting developing countries in trade policy issues, through technical assistance and training programmes
• Cooperating with other international organization
• Providing detailed information on biotechnology, genetically modified (GM) food, and their business
• Dealing with the ethical issues in business
• Helping in smooth and easy conduction of trade at international levels.

 WTO Treaties: The following treaties are enforced by the WTO,

1. General Agreement on Tariffs and Trade (GATT)
2. General Agreement on Trade and Services (GATS)
3. Agreement on Technical Barriers to Trade (TBT)
4. Agreement on Government Procurement (AGP)
5. Agreement on the Application of Sanitary and Phytosanitary Measures (SPS)
6. Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs)
7. Agreement on Trade-Related Investment Measures (STRIMs)
8. Agreement on Agriculture (AOA)

Trade Related Aspects of Intellectual Property Rights (TRIPS)

1. Introduction: Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement between the member nations of World Trade Organization (WTO). TRIPS Agreement is aimed at harmonizing the Intellectual Property (IP) related laws and regulations worldwide.
2. Background and History: One of the important agreements among all of WTO Agreements is the TRIPS Agreement. The TRIPS Agreement has emerged as the most widely impacting agreement post WTO leading to harmonization of IP related laws and regulations among member nations. The TRIPS agreement came into force on 1st January, 1995. Taking into consideration the disparities in economic and technological developments among different member nations, WTO provided for different transition time periods in different member nations for application of these rules.
3. What is TRIPS agreement?

The TRIPS Agreement is an international agreement administered by WTO that sets down minimum standards for many forms of IP regulations. The Agreement, which came into effect on 1st January, 1995 is till date the most comprehensive multilateral agreement on IP. The Agreement covers the following areas of IP: Copyrights and Related rights (i.e. the rights of performers, producers of sound recordings and broadcasting organizations), Trademarks (including service marks), Geographical Indications (including appellations of origin), Industrial Designs, Patents (including the protection of new varieties of plants), Layout-designs of Integrated Circuits and Undisclosed Information (including Trade Secrets and Test Data)   With respect to the above areas of IP, the Agreement governs the following issues:

• How basic principles of the trading system and other international IP agreements should be applied?
• How to give adequate protection to IPR?
• How countries should enforce IPR adequately in their own territories?
• How to settle disputes on IP between members of the WTO?
• Special transitional arrangements during the period when the new system is being introduced.

The Agreement is the first agreement under WTO under which the member nations are required to establish relatively detailed norms within their national legal systems, as well as to establish enforcement measures and procedures meeting minimum standards. The three important features of the Agreement are:

1. Standards
2. Enforcement
3. Dispute Settlement

  Introduction to different forms of IPR To completely protect Intellectual Property (IP) generated in various fields, IPRs are divided into the following forms:

1. Copyright
2. Trademarks
3. Patent
4. Trade secrets
5. Geographical indication
6. Industrial design
7. Plant breeder rights
8. Traditional Knowledge

 

1. Copyright

Copyrights protect IP generated in the filed of art and literature. Examples may include novels, articles, music, and works of the fine arts, such as, paintings and sculptures. Other examples may include technology-based works such as computer programs, maintenance manuals, User Interface (UI), and electronic databases. Copyright laws additionally provide the owner, exclusive rights to reproduce and prepare derivative works, which are derived from IP of the owner. For example, a writer of a novel can prevent others from selling/reproducing his/her novel in a different language. A copyright merely protects expression of an idea and not the idea itself. For example, the writer of the famous novel “Godfather” can prevent other from selling/reproducing this novel in their name. However, if someone uses the plot of Godfather and writes a different novel altogether, then the writer will not be able to prevent him/her.   Rights under copyright can be divided into two types: Economic rights: These allow the owner to have financial benefits from the use of his/her IP. The economic rights can always be transferred by the owner to other individual or an organization. Moral rights: These rights always remain with the owner even if the economic rights have been transferred. Using moral rights, the owner can object to his work (to which economic rights have already been lost), which is being used in a way that may harm reputation of the owner.  

2. Trademarks

A trademark or service mark is a sign or indicator that is used to distinguish products or services provided by any individual or a business organization from their competitors. In short, a trademark is a “brand name”. A trademark can be one of a word, a phrase, a logo, a symbol, a design, a sound mark, a smell or a combination of any of these, which identifies the source of products or services. The two main characteristics for a trademark to be granted are that it should be distinct (non descriptive) and it should not be deceptive. The trademark should not be a generic name for a product or service. For example, the word apple cannot be a trademark of an organization which is growing/distributing apples but it can be a trademark of an organization which manufactures computers. Additionally, the trademark should not potentially mislead someone about certain characteristics of a product or service. For example, using phrase like “pure wool” or “fresh juice” as a trademark may mislead about the characteristics of wool and juice.  

• Google was about to loose its trademark as people started using word “googling” instead of searching.

 

• Xerox and Cornflakes lost their trademark as the word Xerox and Cornflakes became generic terms for their respective service/product.

   

• Patent

A patent is the protection provided to an inventor in the form of exclusive rights for his/her invention. However, this exclusive right is given to the inventors in return of providing a complete disclosure of their invention (along with the details of implementing that invention) while registering for a patent. Patents are granted to encourage inventors to innovate by giving them protection for a time period. Moreover, disclosure of the invention through the patent encourages other people to build on the invention and contribute to innovation. For an invention to be patentable, it must be novel, non-obvious and useful (capable of industrial application). The invention can be any method, apparatus, process, machine, manner of manufacture, substance produced by manufacturing etc.

• The electric shaver was patented in the year 1928.
• Gillette-Mach 3 razor is protected by 33 patents.

 

• Trade secrets

Trade secret may be a formula, practice, process, design, pattern or compilation of information used by an organization to get an advantage over their competitors. Few examples of trade secrets include recipe of a cold drink, a company’s accounting practice, customer specific data available with a company. The trade secret may not be protected by a patent because it is a part of the expertise of people skilled in the art which may loose its economic value after its availability to public.   Trade secrets are not awarded any official protection secrets since they are not disclosed. However, stealing of trade secrets amounts to unfair practices and is punishable under law. To protect the trade secret, the organization should get an agreement signed with all of its employees to prevent these unfair practices. However, if a competitor discovers about a trade secret by using reverse engineering then original owner will not be able to sue the competitor.

• Coca-Cola is one of the best-kept trade secrets in the world. It’s rumored that it is only known to 2 people. This formula is kept in a vault of a Bank in Atlanta, Georgia, and can only be opened by a resolution from the company’s Board of Directors

 

• Employee agreements are trade secrets for organizations

 

• Geographical indication

  When goods or services have some qualities or certain reputation that are by virtue of its geographical origin or location, then they are named or signed by a geographical indication, which indicates its location. For example, recently pashmina shawls were granted GI because pashmina refers to a type of fine kashmiri wool and the textiles made from it. The most famous examples of geographical indications are champagne, cognac, and scotch. Indian companies have been barred to use word ‘scotch’ for selling whisky because ‘scotch’ is GI used for whisky manufactured in Scotland.  

• Industrial design

  An aspect of a useful article that is ornamental or aesthetic is Industrial design. The creation of a shape, configuration, or composition of pattern or color, or combination of pattern and color in 3D form containing aesthetic values comes under Industrial design. The main objective of protecting industrial design is to improve usability and commercial value of mass-produced products for marketability, production and commercialization. Examples of industrial designs include watch designs, jewel designs, automobile designs, textile designs, designs of household articles, electrical equipment and architectural structures. Design Patents come under the category of Industrial Designs.   To obtain the industrial design protection, the design must be new or original and the design should be reproducible by industrial means. There is some degree of overlap between Industrial Designs and copyrights. Therefore, a design can be protected both by a copyright and an industrial design. However, in some countries, the owner has to choose between copyright and industrial design.   PLANT BREEDER RIGHTS These rights are given to provide protection to a new variety of plants to safeguard the interests of plant breeders and act as an incentive to the development of improved plant varieties for agriculture, horticulture and forestry. In order to protect the plant, the plant must be novel, distinct, uniform, stable. Many countries have enacted special legislation, which allows farmers to keep seed or propagating material from one crop for planting of the next.   Traditional Knowledge When community members innovate within the traditional knowledge framework, they may use the patent system to protect their innovations. However, traditional knowledge as such – knowledge that has ancient roots and is often informal and oral – is not protected by conventional intellectual property systems. This has prompted some countries to develop their own sui generis (specific, special) systems for protecting traditional knowledge. There are also many initiatives underway to document traditional knowledge. In most cases the motive is to preserve or disseminate it, or to use it, for example, in environmental management, rather than for the purpose of legal protection. There are nevertheless concerns that if documentation makes traditional knowledge more widely available to the general public, especially if it can be accessed on the Internet, this could lead to misappropriation and use in ways that were not anticipated or intended by traditional knowledge holders. At the same time, documentation can help protect traditional knowledge, for example, by providing a confidential or secret record of traditional knowledge reserved for the relevant community only. Some formal documentation and registries of traditional knowledge support sui generis protection systems, while traditional knowledge databases – such as India’s database on traditional medicine – play a role in defensive protection within the existing IP system. These examples demonstrate the importance of ensuring that documentation of traditional knowledge is linked to an intellectual property strategy and does not take place in a policy or legal vacuum. PATENTS Introduction: An invention is a form of intellectual property (IP) generated by an inventor. An invention is the outcome of an individual’s creativity, which can become a boon for the society. Discovery and inventions are the two terms that should be clarified before we study the patent laws. Discovery means findings already existing in nature, such as the discovery of a new microorganism, new metal from earth’s crust etc. Invention means manual or synthetic design of a material that resembles a natural material. This might be a genetically altered microorganism or entirely a new article like machines, or a new way of doing things as in a process of manufacturing. What is a Patent? A patent is a set of exclusive rights granted by the government of a country to an inventor (or an assignee) for an invention in exchange of full disclosure of the invention.   Purposes of Granting Patent

• Inventors usually spend considerable amount of time and resources in conceptualizing and developing inventions. Therefore, an invention may have a commercial value associated with it and hence may be an asset for an inventor. In order to monetize from the invention and recover the costs of R&D spending, the inventor must be able to control and exploit the use of the invention by others. Thus, it is required that the inventor acquires legal rights over the invention, which entitles the inventor to obtain payment/royalties in exchange for use and ownership of the invention by others.

 

• These exclusive rights empower the inventor to control the manufacture and sale of the invention and to prevent others from making, using, importing or selling the invention. This facilitates the inventors to derive monetary benefits from the invention. Thus, patents reward the inventors for their hard work and ingenuity.

 

• Apart from rewarding the inventors, the purpose of granting a patent is also to promote technological innovation in a country. This in turn helps in industrial development, thereby increasing the economic growth of the country. Also, as the invention is disclosed into the public domain, the dissemination of knowledge for the benefit and use of the public is facilitated. This encourages other inventors to further work on the patented technology to create improved and alternative technologies that might not have otherwise been developed. Thus, patents encourage creativity and innovation in society.

 

• A patent also allows a patentee to sell the invention and the patent rights covered by the patent. Further, the patentee may license the invention to someone else but retain all the patent rights covered by the patent. This facilitates generating new revenue streams through licensing and sale of the patent.

  PATENTABLE SUBJECT MATTER Invention that is eligible for patent protection is known as a patentable subject matter. In the language of the statute, any person who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent,” subject to the conditions and requirements of the law. The word “process” is defined by law as a process, act or method, and primarily includes industrial or technical processes. The term “manufacture” refers to articles that are made, and includes all manufactured articles. The term “composition of matter” relates to chemical compositions and may include mixtures of ingredients as well as new chemical compounds. Non-Patentable Inventions in India All the inventions that are novel and have some inventive step or industrial applicability are not patentable. The above criteria are more or less globally accepted and acknowledged. In contrast to the patentability, an idea, scheme or plan, any scientific principle or mathematic algorithm without any practical application or use is not patentable. Indian Patent Act provides an exhaustive list of non-patentable inventions under Sections 3 and 4. The inventions that are non-patentable include the following:

1. Any invention which is ‘frivolous’ or contrary to well-established natural laws are non-patentable; for example, machine that gives more than 100% performance or perpetual machine.

 

2. Commercial exploitation or primary use of inventions that is contrary to public order or morality are non-patentable. For example, gambling machine, device for house-breaking or anything that causes serious prejudice to health of human, animal, plant life or to the environment are non-patentable. For example, biological warfare, material or device, weapons of mass destruction, terminator gene technology, or embryonic stem cell.

 

3. Mere discovery of a scientific principle or formulation of an abstract theory, discovery of any living thing or discovery of non-living substance occurring in nature are non-patentable. For example, Newton’s laws, superconducting phenomenon as such property of certain material to withstand mechanical shock, discovery of microorganism, discovery of natural gas or a mineral.

 

4. Mere discovery of any new property, new use for a known substance or of the mere use of a known process, machine or apparatus are non-patentable unless such known process results in a new product or employs at least one new reactant. For example, new use of aspirin for heart ailments, mere new uses of Neem (Azadirachta indica).

 

5. Mere arrangement or re-arrangement or duplication of known devices, each functioning independently of one another in a known way is non-patentable. For example, a bucket fitted with torch, an umbrella with fan, a clock and radio in a single cabinet, a flour-mill provided with sieving.

 

6. Method of agriculture or horticulture is non-patentable. For example, method of cultivation of algae, method of vegetative propagation of a plant or method of preparing an improved soil. However, agricultural equipments are patentable.

 

7. Any process for medicinal, surgical, curative, Prophylactic, diagnostic, therapeutic or used for the treatment of human beings or a similar treatment of animals to render them free of disease or to increase their economic value or that of their products are non-patentable. For example, method of removal of cancer/ tumor, removal of dental plaque and carries surgical processes, processes relating to therapy, method of vaccination and blood transfusion. However, surgically therapeutic or diagnostic apparatus or instruments are patentable.

 

8. Plants and animals in whole or any part thereof other than micro-organisms, but including seeds, varieties and species and essentially biological process for production or propagation of plants and animals are non-patentable. For example, clones of animals and plants. However, we have a unique system of plant protection. A process for production of plants or animals if it consists entirely of natural phenomena such as crossing or selection (essentially biological process) is non-patentable.

 

9. Inventions that are traditional knowledge or an aggregation or duplication of known properties of traditionally known component or components are non-patentable. For example, wound healing property of Curcuma longa (haldi), the traditional knowledge of which is already in public domain. However, any value addition using traditional knowledge leading to a new process or product, which is novel with inventive step and industrial applicability like the extraction of ‘Azadirachtin’ from neem plant, is patentable.

 

10. Inventions falling within the Atomic Energy are not patentable as a precautionary measure for national security. “No Patent shall be granted in respect of an invention relating to atomic energy”. For example, inventions relating to compounds of uranium, beryllium, thorium, plutonium, radium, graphite, lithium and more as notified by the Central government from time to time.

  Patentable Ingredients of Biotechnology

1. RNA, DNA or Amino Acid Sequences: Random isolated sequences generally will not be patentable if they have no utility, i.e., they have no known use at the date of filing application. For example, ESTs sequenced without any function or utility is non-patentable.
2. DNA & RNA Vectors: Novel vectors created in lab used for cloning or expressing gene sequences may be patentable.
3. Cell Lines: Artificially produced cell lines are patentable.
4. Gene: A gene to which genetic alterations have been made are patentable, a gene in recombinant form or newly isolated gene in pure form is patentable if its utility or function is known.
5. Protein: Patent protection for a protein may be granted if the protein is not previously characterized or has been isolated from a natural resource in pure form. A novel or known protein obtained through RDT may be patentable. For example, hormone expressed from recombinant vector.
6. Microorganism: A new strain of microorganism produced artificially transformed by recombinant vector is patentable. A microorganism newly isolated in pure form from a natural source is also patentable. A novel product produced by a microorganism is patentable. If a product produced by a microorganism is known, the process of producing the product via microorganism may be patentable.
7. Molecular Biology Techniques: Any novel technique( s) or processes for producing a particular molecular biology product may be patentable.
8. Plant and Animal: Plant varieties may be protected in most industrial countries by way of plant variety rights (also called plant patents). According to plant patents, new asexually reproduced plants can be protected with certain exceptions and ornamental designs in two different ways: Plants Breeder’s Right (PBR), and Patents.

ELIGIBILITY CRITERIA  (CONDITIONS TO BE SATISFIED BY AN INVENTION TO BE PATENTABLE) An invention that is the outcome of an individual’s thought process or creativity has to pass through certain eligibility criteria in order to get a patent. Every invention is not patentable. A patent can be granted for an invention on the following ground:

1. Novelty
2. Non-obviousness
3. Usefulness

 

1. Novelty: A novel invention is one, which has not been disclosed, in the prior art where prior art means everything that has been published, presented or otherwise disclosed to the public on the date of patent(The prior art includes document in foreign languages disclosed in any format in any country of the world).

Novelty is a fundamental requirement for all patents in all the countries, which means that the invention should not be known to the public before filing the application. For example, a lot of objections were raised to the grant of turmeric patent in United States on the grounds that it is not new and people in India have prior knowledge about the same since time immemorial. Novelty of the invention can be spoiled by prior use of the invention before filing an application for the patent, oral description and discussion of the invention in seminar or conferences not within the stipulated time of six months (in India). Throughout the world, one of the following three main systems are adopted by different countries for accessing novelty: Local novelty: an invention must neither be publically used nor published in the particular country in which the applicant seeks patent grant. Ex: New Zealand Relative novelty: an invention must neither be published in any country in the world nor used publically used in the particular country in which the applicant seeks the patent.  Ex: US and Japan Absolute novelty: prior to filing of application, the invention must not have been published or publically used in any country.  

2. Inventive Step: For patenting something, it must provide some advancement or step forward in technology. All elite inventions are said to lack an inventive step if it would be obvious to a person of general skills apart. The degree of thought and imagination required to render an invention patentable will differ. Non-obviousness of patents is considered if the inventor gets an unexpected outcome from the combination of known prior art elements with their known characteristics.

  Non-obviousness and inventive steps are the two terms that reflect a same general patentability requirement present in most patent laws, according to which an invention, in order to be patentable, should be sufficiently inventive or non-obvious. US patent law requires an invention to be non-obvious while European and Indian patent laws require an invention to involve an inventive step. Though this may seem at first to be essentially the same, there are important differences. In Europe, the examiner determines the differences between the invention and the prior art. If there is no difference, the invention is not novel. But if there are differences, the examiner determines what technical problem is solved by adding these elements to the prior art system. If no technical problem is found, it is considered that the invention does not involve an inventive step. While in the USA, the examiner checks the obviousness of the combination of the novel elements without looking for the solution of a technical problem. For determining and evaluating whether an invention is obvious or not, analysis of a Person Having Ordinary Skill In The Art (PHOSITA/POSITA) is considered as a standard. The PHOSITA is a person considered to have average skills and knowledge in a particular technical field.

3. Usefulness: Usefulness is another requirement to apply for patents. The invention should have some industrial applicability and provide benefit to the masses.

  Additional Requirement to Obtain a Valid Patent in Case of Biotechnology Enabling Disclosure: The constraint for enabling disclosure is central to one of the main aims of the patent system, to promote disclosure of information to the public. The specification filed must sufficiently describe the invention along with best methods by which it may be performed in enough details to allow a person of average skill in the relative field to rework the invention without further experimentation. Deposit of Microorganisms: It is essential to the need of filing and enabling disclosure. It is necessary as it would be impossible to accurately describe in writing all the characteristic of the microorganism. A sample can be deposited in a recognized depository like AICC, MTCC etc. Before going for the patent, the microorganism has to be deposited so. CLASSIFICATION OF PATENTS BY WIPO The need for classification of the patent occurred in order to organize and index the technical information contained in patent specification that details the description of the invention and defines contents such as title, abstract, description and claim. Such data helps in retrieving the patent documents to study a particular area of technology and to identify the novelty of an invention. India is a member-state of Word Intellectual Property Organization (WIPO), an international organization responsible for the promotion of the protection of intellectual property throughout the world. According to WIPO, patents are classified as follows:

1. Utility patent
2. Design patent
3. Plant patent

  Utility Patent: Utility patents are given based on usefulness of the invention. Every invention is innovative either in terms of product formation or the method of manufacturing the product. The utilitarian feature of an invention is the criterion for the grant of the patent. The patent provides protection in the way an article is used and works, i.e. it deals with the functionality of the patent. Unlike Standard patent, the Utility model provides protection for the duration of 6 or 10 years without renewal and extension possibilities. Such models are more suitable for inventions for small scale enterprises, which makes minor improvement of the existing inventions. Approximately 90% of the patent documents submitted recently to the PTO are for utility patents. Computer-related inventions that have short commercial life before they go obsolete requires patent monopoly for a short duration of time. Examples of utility patent include duplicate key making machines, coloured eye lens and, calculator cum calender cum timer cum weather reporter. Also biotechnology inventions such as isolation of gene sequences that need to be best protected for a short duration may be brought under a utility patent.   Any invention that is harmful to the environment is not included under utility patent. The utility patent has the following salient features:

• It is fast in order to protect the short commercial life of the invention.
• It is cheaper in terms of filing and maintenance of the patent invention.
• The examination procedure is less complex. It is for a shorter period of time.

Hence, it is also known as ‘petty patent’, ‘innovation patent’, ‘minor patent’ or ‘small patent’.   Design Patent The patent law allows patents to an invention that deals with the shape or ornamental feature of an article. Design patent protects the appearance of the article for 14 years from the date of filing the application but the conditions for design is that it should be novel and unique. The visual feature of the design is embodied in or applied to an article of manufacture. The application of design patent consists of a combination of configuration or shape of the article and surface ornamentation. An ornamental design may be embodied in the entire invention/ article or only on a part of the invention. Design patents are a type of industrial design right. Ornamental designs of jewellery, furniture, beverage containers (coca cola, coke, Pepsi bottles etc.), and computer icons are a few examples of objects that are covered by design patents.   Plant Patent A patent is granted by the government to an inventor who has invented or has discovered new and distinct varieties of plants except tuber-propagated plant or a plant found in uncultivated state. The term of plant patent granted is 20 years from the date of filing the application. It protects the inventor’s right to exclude others from asexually reproducing, selling or using the reproduced plant. This protection is limited to living plants that express only one set of characteristics determined by its genotype through asexual reproduction, which otherwise cannot be made. It includes algae and micro fungi but not bacteria. For a plant variety to get protection, it must be novel, distinct, uniform, and stable. However, plants are protected in India by a special sui generis system. Plant patents do not require maintenance fees.   Classification of Patents in India Type of Patents Awarded in India

S. No.	Types of Patent	Examples
1	Product patent
	(a) Substance	Chemical compounds, enzymes, cell lines, plasmids, recombinant DNA, vector-host, microorganisms
	(b) Composition of matter	Mixture of substances; pharmaceutical composition, food stuffs, composition of fertilizers, lubricant composition
	(c) Devices	Mouse trap, ball-point pen, x-ray tube, fermenter, coffee machine
2	Process Patent
	(a) Manufacturing process	Method of preparing a substance; preparation of a hybrid plasmid, gene cloning techniques, semi-synthetic penicillin or new azo dyes, downstream process of extraction of plant or animal product
	(b) Method of execution	Analytical or diagnostic methods of examination; freeze-drying
	(c) Usefulness	Use of a substance or composition for a particular purpose utilization of herbicides for combating weeds
3	Design Patent	Design and shape of articles like machine, bottles, vehicles etc…

  PATENT OFFICE An application for the patent is filed in the Patent office. The Patent Office is governed by the Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM). This is a subordinate office of the Indian government and administers the Indian law of patents, designs and trade marks. The administration of patent-related matters in India is looked after by the Patents and Trademark Office, which comes under the Department of Industrial Policy and Promotion (DIPP), which has segregated their offices based on different intellectual properties like office for registering design, trademark, IP management etc… These offices for different IPs are located at different places. There are four patent registry offices in India, five trademark registry offices, a GI registry office and an office for NIIMS and patent information. The location city of these offices are given below. Patent Registry Office Kolkata (Head Office) Delhi (Branch Office) Mumbai (Branch Office) Chennai (Branch Office)  Unit 4: PATENT APPLICATION PROCEDURE & DRAFTING   Procedure for granting patents In India, the major steps for granting patents involve

1. Filing of an application for patent with complete specification.
2. Examination of application by Patent office.
3. Advertisement of acceptance of application with complete specification.
4. Opposition to grant of patent if any. The opposition can be made at several steps but before and after the grant, also known as pre-grant and post-grant opposition respectively.
5. Hearing the parties in case of any opposition.
6. Grant and sealing of the patent.

The procedure starts with the filing of patent application.

1. FILING PATENT APPLICATION

Who can apply for a patent? A patent application can be filed either by true and first inventor or his assignee, either alone or jointly with any other person. However, legal representative of any deceased person can also make an application for patent. A patent application has to be filed at the appropriate Patent Office in the prescribed format along with the prescribed fee. An application can either be a provisional application or a complete application. Patent Specification There are two types of patent documents usually known as patent specification. Specification means description of the invention. Every patent application must have specification. Specifications may be provisional or complete. By provisional specification we mean ‘the nature of the invention’ and by complete specification we mean ‘description of the invention’ including drawings, claims and abstract. Thus, it specifies the nature as well as the procedure of formation of the invention in simple and unambiguous language. Provisional Specification: When the applicant finds that his invention has reached a presentable form, then he may prepare a disclosure of the invention in the form of a written description and submit it to the patent office. This disclosure is called a provisional specification. Application for Provisional Specification has to include the nature of the invention. This gives a priority to the applicant over any other person who is likely to file an application for patent in respect of the same invention being developed concurrently in some other part of the world. Although, a patent application accompanied with provisional specification does not confer any legal patent rights to the applicants. The provisional specification is a permanent and independent scientific cum legal document and no amendment is allowed in this. No patent is granted on the basis of a provisional specification. It has to be followed by a complete specification for obtaining a patent for the said invention. Complete specification must be submitted within 12 months of filing the provisional specification. It is not necessary to file an application with provisional specification before the complete specification. An application with complete specification can be filed right at the first instance. Immediately on receiving the provisional specification the patent office accords a filing date for the application and gives a period up to 12 months for filing the Complete Specification during which the applicant can fully develop his invention. If the complete specification is not filed within the prescribed period, the application is treated as deemed to have been abandoned Complete specification Complete specification is a techno-legal document that fully and particularly describes the invention and the best method of performing it. It should contain the following in not more than 30 pages beyond which each page is chargeable as given in the first schedule A patent document (complete specifications) includes the following sections: A Title: The title should give a fair indication of the art or industry to which the invention relates. It should be brief and as precise and definite as possible. The following are not allowable in the title:- a) The Inventor’s name

1. b) The abbreviation “etc”
2. c) The word ‘Patent’
3. d) Fancy words

Field of the Invention: The field of the Invention identifies the technological area to which the invention relates.   Background: The purpose is to clearly bring out the necessity of the invention. It shall clearly specify the technical problems associated with the existing technology and the proposed solution, highlighting the obvious differences between the claimed invention and the prior art. The background section generally cites the prior art in the technological area of the invention and highlights the problems and limitations in the prior art, thereby, bringing out the need of the invention to tackle these problem and limitations.   Summary: The description should include a statement of invention before giving the details of the invention and the method of performing it. The summary section briefly describes various objectives of the invention which are achieved by the invention. The statement should clearly setforth the distinguishing novel features of the invention for which protection is desired.   Detailed description: The detailed description of the invention describes various embodiments of the invention that fall within the scope defined by the claims. The detailed description must provide a written description of the invention in sufficient detail for a PHOSITA to make and use the invention.  It can include example/drawings or both for clearly describing and ascertaining the nature of the invention.   Scope and/or Ambit of the Invention: This part of the specification should bring out the areas of application of the invention and the preferable use of the invention. The applicant can substantiate the industrial applicability of the invention.   Claims: Claims constitute the most important section of the patent document. The claims define the boundary/scope of protection provided to the invention by the patent document.  

2. Examination of application by Patent office

The patent application is not examined automatically after its filing.  The examination is done only after receipt of the request of examination either from the applicant or from third party. The request for examination can be filed within a period of 48 months from the date of priority or date of filing of the application whichever is earlier. After filing the application for the grant of patent, a request for examination is required to be made by the applicant or by third party and thereafter it is taken up for examination by the Patent office. After examination, the Patent office issues an examination report to the applicant which is generally known as First Examination Report (FER). Thereafter the applicant is required to comply with the requirements within a period of 12 months from the date of FER. If the applicant is not able to comply with or meet the requirement within 12 months, or does not submit the documents which were sent to him for compliance within the said period, the application is deemed to have been abandoned.  

3. Advertisement of acceptance of application with complete specification

After filing the application in the Patent Office, all the patent applications are kept secret upto 18 months from the date of filing or priority date whichever is earlier and thereafter they are published in the Official Journal of the Patent Office which is published every week and also available on the IPO website unless they have been withdrawn. After its publication, public can inspect the documents and also may take the photocopy thereof on payment of the fee as prescribed. It is extremely important to publish an application of patent since the inventor claims to have invented a particular method, product or process, which is novel, non-obvious and industrially useful. If after the publication of this work it is found that the invention was not novel or genuine, further stages for the grant of patent will stop and patent will not be granted. Thus, this step of publication is compulsory and precondition for the grant of patent. This period of filing opposition is 6 months and any objection for the publication has to be filed within this time period. If no opposition is filed by that time, next step is taken by the inventor for the grant of patent.

4. Opposition to grant of patent if any

According to Section 25 of Patent Act 1970, anyone who finds that the existing work has already been done, or is wrongly acquired, or it is published earlier and is in knowledge of the people, or there is lack of inventive steps, can file opposition. The opposition filed after the publication of the application is known as pre-grant opposition while the opposition filed after the advertisement of acceptance of complete specification is called post-grant opposition. This can be done within 4 months of acceptance of application. Opposition can also be made if the invention lies in the list of non-patentability or if the information is inadequate. The main objective of this step is to give an opportunity to any person to give a notice of objection. If the applicant successfully passes this step, it can be concluded that no pre-existing data or publication of this work is present; as a result the application may move for further steps like examination.

5. Hearing the parties in case of any opposition.

After receiving the notice of opposition, the patent office grants an opportunity to both the parties to present their argument and if the opponent is found to be correct the application for grant for patent ceases. There are several landmark cases wherein patents were rejected due to oppositions by India. For example, the neem patent challenge, the turmeric patent challenge, and the Hessian patent challenge.

6. Grant of Patent

After the acceptance of the complete specification and disposal of the opposition, a patent is granted. It is then sealed and entered into the register. The request for sealing of the patent is to be made by the applicant within 6 months of acceptance of complete specification. This can only be extended in case if the applicant dies or if the applicants are more than one and any one of them dies. Also, if any application related to the proceeding is pending before the Controller or High Court. The patent is granted for a period of 20 years (according to TRIPS agreement Section 53, amended in 2002) by the patent office in a specific form laid down in Rule 57 of Patent Rules. The patent can be renewed or kept alive by paying a renewal fee according to Section 53(2). Patent grant is given country wise and is effective throughout India. Patent gives the patentee certain rights like holding, using and selling the patent. PCT (Patent Cooperation Treaty) – The International Patent System The PCT is an international agreement with 148 Contracting Counties. The PCT makes it possible to seek patent protection for an invention simultaneously in a large number of countries by filing a single “international” patent application instead of filing several separate national or regional patent applications. Patent Cooperation Treaty (PCT) is administered by WIPO. The treaty was signed on 19 June 1970 at Washington, amended on 28 September 1979 and on 3 February 1984. It was further modified on 3 October 2001. The Patent Cooperation Treaty (PCT) assists applicants in seeking patent protection internationally for their inventions, helps patent Offices with their patent granting decisions, and facilitates public access to a wealth of technical information relating to those inventions.  By filing one international patent application under the PCT, applicants can simultaneously seek protection for an invention in 148 countries throughout the world. The PCT procedure includes

1. Filing
2. International Search
3. International Publication
4. Supplementary International Search (optional)
5. International Preliminary Examination (optional)
6. National Phase
7. Filing

PCT application can be filed by anyone who is a national resident of the contracting state. An international patent application (PTC application) is filed at the receiving office (RO). The receiving office is the branch of PCT where the patent applications are filed. Nationals and residents of India are entitled to file international applications for patents under PCT at Patent Receiving Office, Delhi while for US applicants, the branch office is US patent office. Applicant from any contracting state may file an international patent application at the International Bureau in Geneva. PCT applicants generally pay fee when they file their international applications, an international filing fee of 1,330 Swiss francs (1Swiss francs = 67 rupees). PCT fee reductions are available to all applicants who file electronically, based on the type of filing and the format of the application submitted. In addition, to encourage the use of the PCT System by applicants from developing countries fee reductions of 90% for certain fees, including the international filing fee, are available to natural persons. One can file PCT applications electronically with any competent receiving Offices which accepts such filings. More details about PCT electronic filing can be found at www.wipo.int/pct-safe/en/. Applicant can file an international patent application in any language which the receiving Office accepts. If applicant file his/her application in a language which is not accepted by the ISA that is to carry out the international search, applicant will be required to furnish a translation of the application for the purposes of international search. Receiving Offices are, however, obliged to accept filings in at least one language which is both a language accepted by the competent ISA that is to carry out the international search and a “publication language”, that is, one of the languages in which international patent applications are published (Arabic, Chinese, English, French, German, Japanese, Korean, Portuguese, Russian and Spanish). Applicant therefore always have the option of filing your international patent application in at least one language from which no translation is required for either PCT international search or publication purposes. The patent application can be withdrawn if the inventor or the applicant desires. In such cases, international publication will not take place.

2. International Search

It is an “International Searching Authority” (ISA) (one of the world’s major patent Offices) identifies the published patent documents and technical literature (“prior art”) which may have an influence on whether claimed invention is patentable. PCT makes an international patent search and the search is carried out by one of the major patent offices appointed by the PCT assembly as an International Searching Authority (ISA). The international search report and the written opinion are communicated by the ISA to the applicant. The international search report consists mainly of a listing of references to published patent documents and technical journal articles which might affect the patentability of the invention disclosed in the international application. The report contains indications for each of the documents listed as to their possible relevance to the critical patentability questions of novelty and inventive step (non-obviousness). Together with the search report, the ISA prepares a written opinion on patentability, which will give to applicant a detailed analysis of the potential patentability of his invention. PCT does not issue the patent directly but it helps in the process of filing the patent in foreign countries in the most efficient and cost-effective manner. The following have been appointed by the PCT Contracting States as International Searching Authorities (ISAs): the national Offices of Australia, Austria, Brazil, Canada, China, Chile, Egypt, Finland, India, Israel, Japan, the Republic of Korea, the Russian Federation, Spain, Sweden, Ukraine and the United States of America, and the following regional Offices, the European Patent Office and the Nordic Patent Institute. The availability of a particular ISA to the nationals or residents of a country is determined by the receiving Office where the international application was filed. An international search report which is favorable, that is, in which the documents (prior art) cited would appear not to prevent the grant of a patent, assists applicant in the further processing of his application in those countries in which he wish to obtain protection. If a search report is unfavorable (for example, if it lists documents which challenge the novelty and/or inventive step of your invention), applicants have the opportunity to amend the claims in their international patent application (to better distinguish your invention from those documents), and have them published, or to withdraw the application before it is published.  

3. International Publication

WIPO publishes the international application shortly after the expiration of 18 months from the priority date (if it has not been withdrawn earlier), together with the international search report. PCT international applications are published online on PATENTSCOPE, a powerful, fully searchable database with flexible, multilingual interfaces and translation tools to assist users and the public in understanding the content of published applications. Until international publication (18 months after the priority date), no third party is allowed access to international application unless applicant as applicant request or authorize it.

4. Supplementary International Search (optional)

Supplementary international search permits the applicant to request, in addition to the international search (the “main international search”), one or more supplementary international searches each to be carried out by an ISA other than the ISA which carried out the main international search. The additional search has the potential of reducing the risk of new patent documents and other technical literature being discovered in the national phase since, by requesting supplementary search the applicant can enlarge the linguistic and/or technical scope of the documentation searched. The supplementary international search report is generally similar in content and appearance to the main international search report. However, it does not repeat documents which have already been cited in the international search report, unless this is necessary because of new relevance when read in conjunction with other documents discovered during the supplementary international search.

5. International Preliminary Examination (optional)

International preliminary examination is a second evaluation of the potential patentability of the invention, using the same standards on which the written opinion of the ISA was based. If applicant wish to make amendments to his international application in order to overcome documents identified in the international search report and conclusions made in the written opinion of the ISA, international preliminary examination provides the only possibility to actively participate in the examination process and potentially influence the findings of the examiner before entering the national phase – you can submit amendments and arguments and are entitled to an interview with the examiner. At the end of the procedure, an international preliminary report on patentability (IPRP) will be issued. The International Preliminary Examining Authorities (IPEAs) which carry out the international preliminary examination are the ISAs mentioned above.

6. National Phase

The national phase follows the international phase. It is necessary for an applicant to file a national phase application in each designated country, where protection is sought for, within the time prescribed under PCT, i.e., within 30 months from the priority date. However, this time limit may be increased through national laws by each member country. Indian Patent Law provides a time limit of 31 months from the priority date. Some countries allow extension of such time limit on payment of additional fee. The applicant can enter the national phase in up to138 countries within 30 to 31 months (depends on the laws of the designated countries) from the international filing date or priority date (whichever is earlier). Requirements for national phase include paying national fees and, in some cases, filing translations of the application. These steps must be taken, in relation to the majority of PCT Contracting States’ patent Offices, before the end of the 30th month from the priority date. There may also be other requirements in connection with the entry into the national phase – for example, the appointment of local agents. Once application has entered the national phase, the national or regional patent Offices concerned begin the process of determining whether they will grant applicant a patent. Any examination which these Offices may undertake should be made easier by the PCT international search report and the written opinion and even more by an international preliminary examination report. Biosafety The Assessment of Risk Risk assessment is defined as an estimation of risks in terms of likelihood of occurrence of hazards and severity of their damages. Work with biohazardous agents, needs to be assessed for the risk it poses to the worker, the community, and the environment.  A risk assessment should be done to provide the information needed to eliminate a particular risk OR reduce that risk to an acceptable level. A risk assessment should be done before work begins and should be repeated when changes are to be made in agents, practices, employees, or facilities. Assessing the risk of work with biohazardous agents is not as straightforward as that for inanimate chemical and physical hazards.  Biohazardous microbial agents exist in a variety of environmental places and can express different virulence factors in dynamic host-parasite interactions. Biohazardous agents are classified into four risk groups (RGs). The WHO provided the basic definitions for the classification of infective microorganisms by RG in their Laboratory Biosafety Manual, first published in 1983.   WHO Classification of  Infective  Microorganisms by RG (WHO, 2004) Infective organisms are categorized into four Risk Groups (RGs), reflecting their relative hazards, based upon factors such as

1. pathogenicity,
2. infectious dose,
3. mode of transmission,
4. host range,
5. availability of effective preventive measures, and
6. availability of effective treatment.

  RG 1 (no or low individual and community risk): A microorganism that is unlikely to cause human disease or animal disease RG 2 (moderate individual risk, low community risk): A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock, or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited. RG 3 (high individual risk, low community risk): A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available. RG 4 (high individual and community risk): A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available.   Biosafety Biosafety can be defined as practices that reduce exposure to harmful (biohazardous) organisms and their products, harm in this context meaning causing disease. The organisms referred to are generally microorganisms: bacteria, fungi, viruses, and parasites.   However, many institutions recognize a much broader scope of biohazards, such as cell cultures and venomous vertebrates and invertebrates in addition to human pathogens, oncogenic viruses, prions, and pathogens of plants and other animals.  Thus, biosafety protects not just humans from harm but Earth’s entire biosphere as well. In scientific disciplines, exposures to biohazards may occur while conducting field work or may take place in laboratories.  All laboratories, regardless of discipline or purpose, share a number of hazards. These include toxic chemicals, fire, and electrical shock as well as the potential for injuries from sharp objects and falls. All of these hazards are present in a microbiology laboratory, and most on a day-to-day basis. For microbiology laboratories there is the additional hazard of the potential for exposure to pathogenic microorganisms.   Teaching laboratories in all disciplines are unique in at least one important aspect. As a general rule, and particularly at introductory levels, teaching laboratories tend to be densely populated with large numbers of individuals with limited experience in the hazards of a science laboratory. A certain proportion of them may be immuno-compromised. Other types of laboratories, industrial and research laboratories, are nearly always sparsely occupied by highly trained and experienced workers with well-documented health histories. Thus, this question may be posed: are teaching laboratories less safe than other laboratories?   ESTABLISHING APPROPRIATE BIOSAFETY IN LABORATORY ENVIRONMENTS The Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) have developed standard procedures for working with and providing protection against biological hazards. The publication Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH, 1999) provides specific descriptions of microbiological practices, laboratory facilities, and safety equipment associated with four distinct levels of biosafety required for specific categories of infectious agents. Each biosafety level (BSL) is based on the accepted potential hazard of the agent, as well as the general operations of the laboratory.

1. BSL-1
2. BSL-2
3. BSL-3
4. BSL-4

BSL-1 BSL-1 is appropriate for instruction or experimentation involving well-characterized agents not known to consistently cause disease in healthy adult humans, and of minimal potential hazard to the environment. Examples of BSL-1 agents include

• Bacillus subtilis,
• Lactobacillus species,
• Erwinia species,
• Micrococcus luteus,
• Staphylococcus albus, and
• infectious canine hepatitis virus.

• This laboratory setting typically consists of research taking place on benches without the use of special contaminant equipment.
• A BSL-1 lab, which is not required to be isolated from surrounding facilities, houses activities that require only standard microbial practices, such as:
• Mechanical pipetting only (no mouth pipetting allowed)
• Safe sharps handling
• Avoidance of aerosols
• Daily decontamination of all work surfaces when work is complete
• Hand washing
• Prohibition of food, drink and smoking materials in lab setting
• Personal protective equipment, such as; eye protection, gloves and a lab coat or gown
• Biohazard signs
• BSL-1 labs also requires immediate decontamination after spills. Infection materials are also decontaminated prior to disposal, generally through the use of an autoclave.

BSL-2 Examples of BSL-2 agents include

• Staphylococcus aureus,
• most Enterobacteriaceae,
• Pseudomonas species,
• Clostridium species,
• Mycobacterium leprae,
•  Bordetella pertussis,
• Candida albicans,
• Cryptococcus neoformans, and
• human blood pathogens such as hepatitis B virus (HBV)

In addition to BSL 1, the following practices are required in a BSL 2 lab setting:

• Appropriate personal protective equipment (PPE) must be worn, including lab coats and gloves. Eye protection and face shields can also be worn, as needed.
• All procedures that can cause infection from aerosols are performed within a biological safety cabinet (BSC).
• An autoclave or an alternative method of decontamination is available for proper disposals.
• The laboratory has self-closing, lockable doors.
• A sink and eyewash station should be readily available.
• Biohazard warning signs
• Access to a BSL-2 lab is far more restrictive than a BSL-1 lab. Outside personnel, or those with an increased risk of contamination, are often restricted from entering when work is being conducted.

  Biosafety Level 3 (BSL-3)   Representative Bacterial examples include Mycobacterium tuberculosis, Coxiella burnetii, Francisella tularensis, Coccidioides species.   Examples of BSL-3 viral agents include vesicular stomatitis virus yellow fever virus. Common requirements in a BSL-3 laboratory include:

• Standard personal protective equipment must be worn, and respirators might be required
• Solid-front wraparound gowns, scrub suits or coveralls are often required
• All work with microbes must be performed within an appropriate BSC
• Access hands-free sink and eyewash are available near the exit
• Sustained directional airflow to draw air into the laboratory from clean areas towards potentially contaminated areas (Exhaust air cannot be re-circulated)
• A self closing set of locking doors with access away from general building corridors
• Access to a BSL-3 laboratory is restricted and controlled at all times.
• Laboratory personnel are also under medical surveillance and could receive immunizations for microbes they work with.

    Maximum Containment Laboratories: BSL-4 Examples : Ebola virus Marburg virus In addition to BSL-3 considerations, BSL-4 laboratories have the following containment requirements:

• Personnel are required to change clothing before entering, shower upon exiting
• Decontamination of all materials before exiting
• Personnel must wear appropriate personal protective equipment from prior BSL levels, as well as a full body, air-supplied, positive pressure suit
• A Class III biological safety cabinet
• A BSL-4 laboratory is extremely isolated—often located in a separate building or in an isolated and restricted zone of the building.
• The laboratory also features a dedicated supply and exhaust air, as well as vacuum lines and decontamination systems.

    Safety cabinets A safety cabinet creates a safe working space within the laboratory.  Safety cabinets are designed to protect the worker in the first place and the environment in the second place. A distinction is made between three types of safety cabinets:

1. Class I safety cabinet,
2. Class II safety cabinet
3. Class III safety cabinet.

A class I cabinet is a fume hood in which exhaust air passes through a HEPA filter. This type of cabinet provides protection to worker, but no experiment protection.   Class II safety cabinets

• A class II safety cabinet provides protection to worker, environment and experiment.
• These cabinets have a downward laminar airflow.

Class III safety cabinets A class III safety cabinet provides maximum protection to the worker and the environment. The experiment, is less protected, because there is no downward air flow inside the cabinet.  A class III cabinet is completely sealed, and arm-length rubber gloves are attached to ports in the cabinet in a gas-tight manner to allow for manipulation of the materials isolated inside. Materials are brought into and removed from the cabinet through a small air-lock or double-ended autoclave.   HIGHLIGHTS OF THE CARTAGENA PROTOCOL ON BIOSAFETY What is biosafety? Biosafety is a term used to describe efforts to reduce and eliminate the potential risks resulting from biotechnology and its products. What is Cartagena Protocol on Biosafety? The Cartagena Protocol on Biosafety is “an international agreement which aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on biological diversity and risks to human health”. It was adopted on 29 January 2000 and entered into force on 11 September 2003. Background of the Cartagena Protocol:

• The origin of the Cartagena Protocol dates back to the 1992 when United Nations Conference on Environment and Development, held in Rio de Janeiro in Brazil.
• At that meeting, more than 178 governments adopted an Agenda.
• Agenda was a comprehensive action plan for dealing with ways in which human activities affect the environment; it included a chapter on ‘environmentally sound management of biotechnology’.
• At the same meeting, the Convention on Biological Diversity (CBD) was opened for signing in 1992.

The 3 principal objectives of this Convention are as follows:

1. – the conservation of biodiversity
2. – the sustainable use of its components
3. – the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources.

Why do we need an international biosafety agreement?

• One of the issues addressed by the CBD is biosafety, i.e. the need to protect human health and the environment from the potential adverse effects of the products of modern biotechnology.
• At the same time, biotechnology is recognized as having great potential for the promotion of human well-being and for the sound management of the environment.
• The CBD clearly recognizes these twin aspects of biotechnology and includes provisions for both the promotion of biotechnology and the development of procedures to ensure its safety.
• The highest decision-making body of the CBD, the Conference of the Parties (COP), subsequently decided to develop a biosafety protocol, and established the Open ended Working Group on Biosafety for this purpose, which met six times between 1996 and 1999.
• The protocol was adopted by an Extraordinary meeting of the COP which began in Cartagena, Colombia, in February 1999 and concluded in Montreal in January 2000.

Why do we need an international biosafety agreement?

• One of the issues addressed by the CBD is biosafety, i.e. the need to protect human health and the environment from the potential adverse effects of the products of modern biotechnology.
• At the same time, biotechnology is recognized as having great potential for the promotion of human well-being and for the sound management of the environment.
• The CBD clearly recognizes these twin aspects of biotechnology and includes provisions for both the promotion of biotechnology and the development of procedures to ensure its safety.
• The highest decision-making body of the CBD, the Conference of the Parties (COP), subsequently decided to develop a biosafety protocol, and established the Open ended Working Group on Biosafety for this purpose, which met six times between 1996 and 1999.
• The protocol was adopted by an Extraordinary meeting of the COP which began in Cartagena, Colombia, in February 1999 and concluded in Montreal in January 2000.
• The Protocol entered into force on 11 September 2003.
• Currently 170 countries are Parties to the Protocol.
• India is a party of Cartagena Protocol (Joined in Jan 23, 2003).

  What is the exact name of the Biosafety Protocol?

• The full name of the Biosafety Protocol is “the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.”
• Cartagena is the name of the city in Colombia where the Biosafety Protocol was originally scheduled to be concluded and adopted in February 1999.
• However, due to a number of outstanding issues, the Protocol was finalized and adopted a year later on 29 January 2000 in Montreal, Canada.

  What is the objective of the Protocol ?

• “contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of LMOs resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements”.
• The Protocol promotes biosafety by establishing rules and procedures for the safe transfer, handling, and use of LMOs.
• It includes Advance Informed Agreement (AIA) procedures for imports of LMOs for intentional introduction into the environment, and also incorporates the precautionary approach, and mechanisms for risk assessment and risk management.
• The Protocol establishes a Biosafety Clearing-House (BCH) to facilitate information exchange between the parties.

Parties are required to use the BCH to communicate to other Parties, their contact information, regulatory frameworks, results of import decisions, results of risk assessments, occurrences of unintentional transboundary movements of LMOs, and several other types of information.

• The Protocol attempts to resolve the respective needs of trade and environmental protection in the light of rapidly growing biotechnology industry.
• The Protocol addresses the obligations of Parties in relation to the transboundary movements of LMOs to and from non-Parties to the Protocol.
• The main function of the governing body of the Protocol known as the Conference of the Parties (COP) to the Convention serving as the Meeting of the Parties (MOP) to the Protocol i.e. COP-MOP is to review the implementation of the Protocol and make decisions or provide necessary guidance to promote its effective operation.
• Till date 7 meetings of COP-MOP have been convened.
• India hosted the 6^th meeting at Hyderabad from 1- 5^th October 2012.

  What are the benefits of becoming a Party to the Protocol?

1. Influence on the implementation of the Protocol and shaping of its further development through participation in the decision-making processes of the Conference of the Parties serving as the meeting of the Parties to the Protocol;
2. For developing country Parties and Parties with economies in transition, eligibility for financial support from the Global Environment Facility for capacity-building, as well as other support for implementation of the Protocol and participation in its processes;
3. Enhanced visibility and honesty of national systems for regulating biosafety within the global community;
4. Contribution to harmonized rules, procedures and practices in managing the transboundary movement of LMOs;
5. Assistance of mechanisms and opportunities for governments to collaborate with other governments, the private sector and civil society on strengthening biosafety;
6. Improved access to relevant technologies and data, and benefiting from a regular exchange of information and expertise; and
7. Demonstration of commitment to conservation and sustainable use of biological diversity through the implementation of biosafety measures.

  BIOETHICS Needs and definition of Bioethics Ethics refers to the moral value of what is good or what is bad and the individual judgments on values. These judgments are based on cultural and religious beliefs. Bioethics is a compound word: bio represents life and therefore bioethics means concerning  life with ethics. Bioethics is the discipline that studies the actions permitted by biotechnology – actions like cloning or genetic engineering – and asks whether or not these actions are morally acceptable, and if so how we should manage them socially in order to promote citizens’ welfare, protect their rights and treat them fairly. The purpose of  bioethics is to deal with the ethical and value issues that have surfaced due to the rapid development of science, technology and biomedicine during the last two decades. Areas in biotechnology that raise ethical and related questions   These areas can be classified into four groups:

1. Agriculture,
2. Medical and health care,
3. Reproduction
4. Defence.

• Genetic engineering,
• Tissue culture,
• New materials such as biopesticides,
• Gene therapy,
• Stem cells,
• Plant-based drug formulations,
• Organ transplantation,
• Bioinformatics,
• ART,
• DNA fingerprinting,
• Cloning
• Biological weapons.

Ethical and related issues in biotechnology

1. Release of genetically manipulated organisms (GMOs)

Release of living organisms in an environment in which they were absent earlier, has led to enormous damage. For example, in India, Parthenium and water hyacinth were unknown at the beginning of the 1950s Since then, they have become major problems. Both these plants have spread all over the country. Parthenium allergy is one of the most common allergies in India today, and water hyacinth has choked numerous lakes, river beds and water passages. Both have led to an enormous expenditure in remedying or controlling the situation arising out of their spread across the country. The origin of these plants is not absolutely clear, though it is believed that Parthenium came as a weed along with the supplies of wheat from the US to India before the green revolution in India. Therefore, it is only appropriate that no genetically modified organism is released in the environment unless it has been appropriately tested. Unfortunately, no GMO released so far in the world – including India – has gone through such rigorous testing. The first GMO that was approved to be released in a limited way in India was an Indian version of Monsanto’s Bt cotton containing an insecticidal gene from Bacillus thuringenesis developed by the Indian company, MAHYCO, in collaboration with Monsanto. There has been wide spread criticism about its release permitted by the Government of India in 2002, as this was done ignoring the ground realities in India such as the fact that, unlike in the US where bollworm is the main cotton pest, we have numerous other pests associated with cotton that are not susceptible to the Bt toxin.It was, therefore, no surprise that this Bt cotton failed in several parts of the country. The sad part of the story is that, in spite of this, Government of India renewed the permission to Mahyco to continue to market and try the same Bt cotton in several other parts of the country.

2. Stem cells

In India, the work on stem cells is fortunately being encouraged. There have been no protests from any quarter in regard to work on stem cells in India. This is in contrast to the stand of the President of the US in regard to research using human stem cells. There is clearly a need for an international stem cell agreement.

3. Organ transplantation

As is widely known, the pig seems to be the most suitable animal for xenotransplantation of organs on humans. Transplantation of organs from such a pig on to a human being would then be no different from homo-transplantation, for the success of which the protocols are already available and well established. When this becomes a reality, what about the Islamic world? Will they accept a pig organ for, for them, pig is an unholy animal.

4. Assisted reproductive technologies and cloning

The most important ethical question in ART is: who should be the sperm or egg donor and who may act as the surrogate mother. In India, so far, the sperm and egg donors have been close relatives or close friends of the infertile couple or their families. In the case of surrogacy, again, it is generally a close relative who agrees to act as a surrogate mother for a couple who cannot or do not want to carry their own child. Traditionally, if a couple is infertile in India, the family places the blame on the woman even though we know today that in about half the diagnosable cases a male factor is the cause of infertility. Even if the mother-in-law is convinced that her son has a problem, she would want this to be kept as close a secret as possible. She, therefore, takes the daughter-in-law to an infertility clinic and asks the doctor to inseminate her by the semen of the husband’s brother or of a close family friend. The daughter-in law would normally have no say in this regard. The psychological stress that she will go through for the rest of her life, including during pregnancy, on account of the knowledge that the biological father of the child she is carrying is someone whom she knows and has social interaction with all the time, would not be generally a matter of concern to the rest of the family in India.   Now imagine the following scenario. A few years later, the mother-in-law and the daughter-in-law quarrel which is not uncommon in our country as the joint family system is still in vogue but under pressure on account of the changed circumstances. The mother-in-law says publicly that her daughter-in-law has committed adultery and names the person with whom, according to her, the adultery has been committed. DNA fingerprinting will establish that the basis of mother-in-law‘s allegation that the child is not the daughter-in-law’s husband’s child but of another man is correct, as infertility clinics are, as of today, not required to keep appropriate records. There will be no way that the daughter-in-law can establish that she never slept with the man who is the biological father of the child and that she was – in spite of her protestations – artificially inseminated with his semen on account of the insistence of the mother-in-law, which is not adultery. Such situations, and many variations of it, make the use of the semen of a person known to the infertile couple or their family, for artificial insemination, unethical.   Another unusual case which would support the view that the practice that is being followed today in India – that is, of using sperm or egg of a person intimately known to the family – is unethical. One woman – more courageous and self-reliant than usual – was taken by her mother-in-law to an infertility clinic to be inseminated at an appropriate time later by the semen of a close friend of the husband, whom the woman knew well. An advance was paid to the clinic for the procedure of AID (artificial insemination by donor semen) to be performed on the woman later on. Some time later, the woman went back to the clinic, this time all by herself, and asked that the money that was paid to the clinic as advance on her behalf, be returned to the woman. When the clinic asked as to why this request was being made, the woman said that this was so because she was now pregnant. The doctors at the clinic were naturally puzzled and asked her as to how she became pregnant. She then answered that since she was going to be inseminated by the semen of her husband’s friend, whom she knew very well, she saw no harm in going and sleeping with him at an appropriate time just for once. The pregnancy was a natural consequence of this act which she did not consider as unethical, for she had promised to herself that she will never sleep with that man again. She clearly did not perceive any difference between being inseminated by the semen of a person whom she knew very well, and sleeping with him just once for achieving the objective of AID without having the family spend any money. I leave it to the readers to judge whether, given the circumstances I have mentioned, what she did was ethical or unethical. Ethical and social issues associated with Surrogate pregnancies Who may act as the surrogate mother? The mother of the male partner OR the sister of the female partner. In many cases in the country, a woman has given birth to her own grandchild. On the other hand, there are also regular advertisements, for example in the magazine, Woman’s Era, for surrogate motherhood.   It is believed that it is unethical to have a close relative act as a surrogate mother, especially in the Indian environment where family ties are very close. In a closely-knit family, the fact that the child was carried in the womb and then delivered by so-and-so will always be known to the members of the family and, eventually, to the child after it grows older.  Carrying a child in one’s own womb is, in Indian society, the indication of a close relationship. Therefore, it would be difficult for a child and the surrogate mother, if they see each other everyday, for such a relationship not to come in the way of the child establishing the expected relationship with the biological mother, without confusion in the child’s mind. The ideal solution would be what is already being practiced by some country, that is, to advertise for a surrogate on payment basis that will adequately compensate the woman who agrees to act as a surrogate mother.   Lack of transparency in surrogacy can lead to some funny situations, as has happened in India.

• In 2001, a woman came to one of the best-known maternity hospitals in Hyderabad to be admitted for delivery.
• She wanted to be registered in the name of her sister, as she was acting as a surrogate mother for her sister’s and brother-in-law’s child.
• Not having handled such a case earlier, the doctor-in-charge of the hospital, an eminent and highly ethical person, agreed to this request, only to realize a little later that this was a mistake.
• What would she do in case the woman died during childbirth? Whose death certificate would she sign – of the sister in whose name the woman had registered, or of the woman herself?
• This is an outstanding example of the lack of transparency leading to a difficult situation.

  The Indian preference for a male child   In India, all through history, there has been a preference for a boy. The reasons for this have been many…….. A girl child becomes a financial burden on the parents.

• India is, in fact, today known for the large number of dowry deaths where the young bride either kills herself or is killed by her in-laws for refusing to ask her parents, after the marriage, for more money, in addition to what was initially agreed upon as the dowry to be paid by the girl’s family.
• Under the above circumstances, there is an extreme desire on the part of a vast majority of Indian couples to use modern technology to ensure the birth of only a male child.
• One way in which this can be achieved is by abortion of the female fetuses.
• Therefore, the Government of India enacted a law prohibiting prenatal sex determination (excepting for medical reasons, such as the possibility of the fetus suffering from a genetic disorder).
• However, the ground reality in India is that such a law is extremely difficult to implement and, as of today, is followed more in breach than in practice. This is a major ethical problem in the country today.
• The situation is made worse by advertisements in our newspapers by some infertility clinics that they can give the couple a child of the desired sex, which, as it turns out, is always a male, by prenatal sex selection, that is, by using the technology of separating X and Y spermatozoa.
• The protagonists of these technologies argue in the following way.
• They say that if a couple already has a child of a particular sex and wants to have a child of the other sex as the second child to balance their family,

     Why should we not allow modern technology to be used for this purpose?

• They indicate, at least for argument’s sake, that if the first child is a boy and they want to have a second child, why should we not permit them to abort a male fetus in the second pregnancy, or permit the woman to be inseminated artificially with an X-enriched sperm fraction of the spermatozoa obtained from the husband.
• Keeping in mind the situation obtained with the vast majority in the country, who, today, consider a girl child a burden and a boy child an asset, and the fact that the female : male ratio in the country has declined to socially dangerous levels.
• Such differences in Indian attitudes creating ethical and social issue.

 

5. Plant-based drug formulations

In India, there are some 40,000 plant-based drug formulations that are a part of the 4 documented Indian systems of medicine – the Ayurveda, the Unani, the Siddha, and the Tibetian systems – and the undocumented tribal systems of medicine. Some 7,000 plants are already known to be used in these formulations, and there are another 3,000 plants waiting to be documented as most tribal formulations are still not in public domain. Suppose you have obtained a traditional plant-based drug formulation from a tribe that the tribe has been using for 1000 years. And then you will  subject it a rigorous procedure of standardization and validation to find out whether it works or not. And it turns out that it works. You then commercialize and make money out of it, without sharing it with the tribe.

• Would it be ethical?
• And even if you wished to share the profits, how much should go to the tribe?

  There is a plant called Phyllanthus amarus, which has been used widely in virtually all parts of our country in several indigenous medical systems of ours, as well as in many other parts of the world, to cure certain liver disorders.  Since the use of our traditional drugs is based on symptoms, what is understood that the above plant-based drug formulation could take care of certain symptoms, without the disease as we know of it today having been identified. What the Nobel prize-winning scientist, Barry Blumberg, who discovered the hepatitis B virus, did was to show that extracts of Phyllanthus amarus inhibited two key enzymes of the hepatitis B virus, and eliminated the virus from the system in an animal model, thus indicating that the extract could be a cure for human hepatitis B and might even eradicate the hepatitis B virus from the nearly 300 million carriers of the virus around the world. He obtained two patents on this work , not giving any credit to ancient Indian tradition for use of the plant for curing symptoms which correspond, amongst other diseases, to hepatitis B. Legally, these patents could not be challenged, as none of the ancient medical systems in our country ever claimed to have cured hepatitis B using extracts of Phyllanthus amarus. However, were these patents morally or ethically justified?

6. Bioinformatics

Using DNA chips, it would be possible for a physician to tell a parent as to what the diseases are that a new-born child is likely to suffer from as it grows up. There is no problem for a physician if the disease is like sickle-cell anemia, or thallasemia, or cystic fibrosis as, in such cases, the child is bound to suffer from the disease. Genetic disorders can be classified broadly into two categories. In the case of one category, if you carry the particular defective gene(s), you are bound to suffer from the disorder sooner or later in your life. This is the case with sickle cell anaemia, thalassaemia, cystic fibrosis, haemophilia or albinism. There are, however, a much large number of genes, called the susceptibility genes, the presence of which only makes one susceptible to the disease sometime in the person’s life.  As of today, we do not know what environmental or life style factors are responsible for converting the susceptibility status in such cases, to the diseased status later in the life of an individual. All that we can say today in this regard is based entirely on statistical data; so we can only say what the chances are of a person having a particular susceptibility gene, becoming diseased later in life.   In case of susceptibility genes, the doctor can only indicate the chances that the child would have of suffering from the disease – let us say, type II diabetes? We still do not know what are the life-style or other factors that lead to the conversion of the susceptibility status to the disease status in the carriers of such genes.  In the absence of this knowledge, let us assume that the physician tells the mother that there are 50%  chances of her child suffering from diabetes after the child crosses age  40. But it happens that the child doesn’t suffer from the disease and leads a normal life all through. Could he, later, take legal action against the doctor for keeping him and his family under suspense that he may suffer from the disease? On the other hand, if the physician does not tell the parent about the presence of the gene in the child, and it turns out that the child does suffer from the disease when it grows up, the child and the parent can again take legal action against the doctor saying that he withheld information which could have prepared them for the disease scenario. How do we tackle this problem?  

7. DNA fingerprinting

It is surprising that such a useful and clean technology as DNA fingerprinting can raise ethical question…………… But here is one example…. A case of immigration was referred to the Centre for Cellular and Molecular Biology (CCMB) at Hyderabad for a DNA fingerprint by the British immigration authorities.  In this case, an Indian couple living in England with two children had a third child in India while they were visiting the country. When they wished to take the third child back to England, the immigration authorities asked them to establish that they were the biological parents of the child, to rule out the possibility that they were bringing an abandoned child for sale in the United Kingdom. The case was referred to the CCMB for DNA fingerprinting. When Lalji Singh, the former Director of CCMB, did the DNA fingerprinting of the entire family, he found that while the child born in India was the child of the husband and wife who were taking it to the UK, one of the two children living with them in England was not their child. The wife had committed adultery without the husband being aware of it. The question that Lalji Singh faced was “what to say to the immigration authorities”. If the truth was told to them and later became known to the parents, the family might break up. On the other hand, would hiding the truth be ethical?  What Lalji Singh finally decided was to answer only the question that he was asked by the immigration authorities, and keep to himself the other relevant information that he had. Did Lalji Singh do the right thing?

8. Biological weapons

Biological warfare is upon us. We can today design ethnic weapons that would affect only a particular segment of world’s population. For example, Americans over age 50 are known to have a depleted immune response. Therefore, certain pathogenic organisms released in the environment would be likely to affect only the elderly Americans but would leave the Indians, completely unaffected. The depleted immune response in the older Americans could to be a fact that they have lived in a virtually semi-sterile environment so that their immune system has not been challenged enough. On the other hand, we in India are being continuously challenged by low levels of infection in our environment and, therefore, our immune system is robust. We can thus exploit this advantage to produce an ethnic-specific weapon. Would that be ethical? Great Britain, the US, the USSR (now Russia), Canada, Germany, South Africa, Japan, Iraq, Iran, Syria and North Korea are known to have had extensive biological weapons development programme. The list of biological weapons on which considerable work has been done includes nearly 60 bacteria, viruses, other organisms, and toxins. Examples would be: Viruses that cause smallpox, Ebola fever, Marburg fever, Lassa fever, and various haemorrhagic fevers;  Bacteria that cause anthrax, plague, glanders and tularemia; and Toxins such as botulin and ricin. Botulin is the most deadly poison known to us, its LD50 (the amount required o kill 50 percent of the exposed individuals) for human beings being 6 nanograms per kilogram weight, that is, approximately 40 nano-grams per person.  We may thus need just half-a-kilogram of botulin to kill the entire population of the world, and the delivery of it would be easy: just put it in the water supplies as botulin is an intestinal toxin. There is, indeed, no doubt that biological weapons are the most dreaded ones today – far most dangerous than nuclear, chemical or conventional weapons.

9. Tissue culture

One would normally think of tissue culture as one of the safest biotechnologies which is neither polluting nor likely to pose any ethical or related problems, But look at this possible scenario….. We are all familiar with the fragrance of vanillin. Till recently, the entire supply of vanillin of the world came from Malagasy Republic where some 70,000 farmers have been involved in cultivation of vanillin. Now, vanillin is likely to be produced more cheaply through tissue culture by American and Japanese companies. Therefore, no market for vanillin produced naturally, and the 70,000 farmers may be facing unemployment? Will this be fair? There is a protein called thaumatin found in a particular plant endemic to parts of Africa such as Nigeria. Thaumatin is 5000 times sweeter than sugar and is completely non-toxic. Being a protein, it is degraded in the digestive tract after ingestion, and therefore, does not get into the blood stream. It has also been produced through genetic engineering. It is believed that it may not be difficult to make it 50,000 times sweeter than sugar. Once we do that, we can produce it at a cost that would be a fraction of the cost of the cheapest cane sugar or beet sugar around the world. If that happens, some 7 million workers in the sugarcane industry in the Third World alone may face unemployment. This would be a major socio-economic problem. How should we support ourselves to face it? Is cloning ethical? Cloning an individual and harvesting the embryonic stem cells, OR allowing the fetus to grow to a stage where organogenesis has begun so that one could harvest the organs. They could then be further grown in the laboratory to give the desired organ for transplantation. In such cases, there will be no immunological rejection of any kind and one would not need to be on expensive immunosuppressive agents like cyclosporin, as is the case with organ transplantation (from another individual) today. No two individuals (except identical twins, who are like clones of each other) are immunologically identical; without an immunosuppressive drug, the transplanted organ will be rejected in most cases.   It appears that in India, there is likely to be no significant opposition to therapeutic cloning, as opposed to reproductive cloning for producing full-fledged living replicas of an individual. The argument against reproductive cloning is that, we all are a consequence of two factors: the genetic and the environmental. Our DNA determines our capabilities, while the environment determines the nature and the extent to which these capabilities would be converted into abilities, as we grow up. The environment of the clone would be different from the environment in which the person who is being cloned was brought up, day-by-day, year-by-year.   Therefore, a human clone produced from the somatic cell is extremely unlikely to be identical with the individual who is being cloned; The similarity between the two would probably be near what is observed in identical twins. Therefore, reproductive cloning would seem to serve no purpose.